二甲双胍恩格列净片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号DC033-12306002对照品来源中检院对照品使用方法直接使用
对照品含量(%)98.99对照品水分(%)0对照品稀释倍数2000
标示量(mg)5供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.26 2418332424712425272423842411302420690.25
210.312388262382982385620.16
单位质量响应值RSD%判断
23593.4723138.891.38数据可信
供试品溶液-24052801批-恩格列净-pH6.8
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1144591-14459155.13543.3616.5155.1443.3616.51
2121624-12162446.37746.38
3102834-10283439.21239.21
4101466-10146638.69138.69
5119174-11917445.44345.44
692582-9258235.30335.30
10min1210887-21088780.41575.356.7780.5175.426.78
2207157-20715778.99379.07
3188530-18853071.89071.96
4186875-18687571.25971.32
5210618-21061880.31280.39
6181499-18149969.20969.27
15min1231199-23119988.16086.202.2688.3986.392.28
2224223-22422385.50085.71
3225401-22540185.94986.13
4220184-22018483.96084.14
5233129-23312988.89689.11
6222138-22213884.70584.88
20min1233082-23308288.87888.021.1789.2588.361.18
2227775-22777586.85587.21
3231466-23146688.26288.59
4230975-23097588.07588.40
5234097-23409789.26589.62
6227523-22752386.75987.07
30min1232679-23267988.72588.381.0789.2588.861.07
2227980-22798086.93387.43
3232826-23282688.78189.26
4233353-23335388.98289.45
5234289-23428989.33989.85
6229448-22944887.49387.95
45min1233813-23381389.15788.451.3089.8389.081.30
2228162-22816287.00287.64
3233445-23344589.01789.64
4233501-23350189.03889.66
5234719-23471989.50390.16
6228092-22809286.97687.58
60min1232852-23285288.79188.491.0689.6189.281.06
2228404-22840487.09587.88
3233346-23334688.97989.75
4234257-23425789.32690.09
5233935-23393589.20490.01
6229626-22962687.56188.31
极限1233066-23306688.87288.661.2089.8489.591.19
2229691-22969187.58588.52
3234381-23438189.37490.29
4235461-23546189.78590.70
5233892-23389289.18790.14
6228505-22850587.13388.03
二甲双胍恩格列净片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号DA-11412209074对照品来源工作对照品对照品使用方法直接使用
对照品含量(%)99.9对照品水分(%)0对照品稀释倍数20
标示量(mg)500供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
19.981059630106199610626131064261106013310617270.18
210.081058407106078010595940.16
单位质量响应值RSD%判断
106385.47105118.450.85数据可信
供试品溶液-24052801批-二甲双胍-pH6.8
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1836475-83647571.11957.9113.7371.1257.9113.73
2723320-72332061.49961.50
3624536-62453653.10053.10
4611819-61181952.01952.02
5705310-70531059.96759.97
6585220-58522049.75749.76
10min11108105-110810594.21489.215.3194.3389.305.32
21097079-109707993.27793.38
31006501-100650185.57585.66
4993452-99345284.46684.55
51093823-109382393.00093.10
6996420-99642084.71884.80
15min11177764-1177764100.13797.961.62100.4198.211.63
21151204-115120497.87998.14
31143497-114349797.22397.45
41125459-112545995.69095.92
51168373-116837399.33899.59
61146996-114699697.52197.74
20min11178387-1178387100.19099.320.49100.6399.720.50
21164062-116406298.97299.39
31164622-116462299.01999.41
41165973-116597399.13499.52
51170925-117092599.55599.98
61164686-116468699.02599.41
30min11177524-1177524100.11699.250.53100.7399.820.54
21159134-115913498.55399.14
31165681-116568199.10999.67
41169868-116986899.465100.02
51167359-116735999.25299.84
61164135-116413598.97899.53
45min11180847-1180847100.39999.300.62101.18100.040.63
21160100-116010098.63599.39
31167557-116755799.26999.99
41167459-116745999.26199.98
51168822-116882299.376100.13
61162752-116275298.86099.58
60min11177476-1177476100.11299.190.53101.06100.090.54
21159638-115963898.59699.51
31164588-116458899.01699.91
41168308-116830899.333100.22
51166347-116634799.166100.08
61163078-116307898.88899.77
极限11172142-117214299.65998.990.47100.77100.060.47
21158177-115817798.47199.55
31162589-116258998.84799.90
41168737-116873799.369100.42
51164309-116430998.993100.08
61159604-115960498.59399.64
二甲双胍恩格列净片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号DC033-12306002对照品来源中检院对照品使用方法直接使用
对照品含量(%)98.99对照品水分(%)0对照品稀释倍数2000
标示量(mg)5供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.26 2380602379522374402370942370282375150.21
210.312375042373652374340.05
单位质量响应值RSD%判断
23149.6123029.490.37数据可信
供试品溶液-24052802批-恩格列净-pH6.8
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1115011-11501144.37742.6610.4344.3842.6610.43
2102900-10290039.70439.70
3102965-10296539.72939.73
4123034-12303447.47347.47
5123383-12338347.60847.61
696121-9612137.08937.09
10min1212611-21261182.03679.745.0382.1179.815.04
2196270-19627075.73175.80
3198606-19860676.63376.70
4219196-21919684.57784.66
5215972-21597283.33383.41
6197277-19727776.12076.18
15min1246746-24674695.20893.711.9795.4293.911.98
2235203-23520390.75490.95
3243288-24328893.87394.07
4248826-24882696.01096.23
5242370-24237093.51993.74
6240699-24069992.87493.06
20min1249766-24976696.37395.871.4196.7496.231.41
2243730-24373094.04494.39
3250092-25009296.49996.85
4252568-25256897.45497.83
5244575-24457594.37094.74
6250008-25000896.46696.81
30min1251336-25133696.97996.181.3497.5196.701.34
2244986-24498694.52895.03
3251031-25103196.86197.37
4251696-25169697.11897.66
5244972-24497294.52395.05
6251609-25160997.08497.59
45min1251770-25177097.14696.591.3497.8497.271.33
2246544-24654495.13095.79
3252376-25237697.38098.05
4252439-25243997.40498.11
5245619-24561994.77395.46
6253205-25320597.70098.37
60min1251691-25169197.11696.411.2297.9797.251.22
2246417-24641795.08195.90
3251454-25145497.02497.86
4251978-25197897.22698.09
5245508-24550894.73095.58
6252110-25211097.27798.11
极限1255737-25573798.67798.651.3399.6999.651.32
2251963-25196397.22198.20
3257377-25737799.310100.31
4257349-25734999.299100.33
5251446-25144697.02198.03
6260125-260125100.370101.36
二甲双胍恩格列净片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号DA-11412209074对照品来源工作对照品对照品使用方法直接使用
对照品含量(%)99.9对照品水分(%)0对照品稀释倍数20
标示量(mg)500供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
19.981055920105478610562741055029105503410554090.07
210.081057059105730010571800.02
单位质量响应值RSD%判断
105752.40104878.970.59数据可信
供试品溶液-24052802批-二甲双胍-pH6.8
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1654423-65442355.87054.378.2955.8754.388.29
2603409-60340951.51551.52
3605236-60523651.67151.67
4692557-69255759.12659.13
5697571-69757159.55459.55
6568197-56819748.50948.51
10min11051473-105147389.76888.073.7689.8688.163.76
2994823-99482384.93185.02
31004104-100410485.72485.81
41074240-107424091.71191.81
51072440-107244091.55891.66
6992664-99266484.74784.83
15min11156175-115617598.70798.260.9998.9598.490.99
21131291-113129196.58296.81
31158087-115808798.87099.10
41163160-116316099.30399.55
51150371-115037198.21198.46
61146278-114627897.86298.08
20min11156803-115680398.76099.270.8999.1799.670.88
21154543-115454398.56798.96
31172696-1172696100.117100.51
41171318-117131899.999100.42
51149451-114945198.13398.55
61171647-1171647100.027100.41
30min11157533-115753398.82299.330.8599.3999.900.84
21159494-115949498.99099.54
31174885-1174885100.304100.86
41166873-116687399.620100.20
51149419-114941998.13098.71
61172891-1172891100.134100.69
45min11159332-115933298.97699.400.7999.71100.140.78
21157510-115751098.82199.54
31174709-1174709100.289101.02
41167014-116701499.632100.38
51152975-115297598.43399.18
61174581-1174581100.278101.00
60min11157704-115770498.83799.170.8399.74100.070.83
21156384-115638498.72499.61
31173219-1173219100.162101.06
41164189-116418999.391100.31
51147642-114764297.97898.88
61170815-117081599.956100.84
极限11155276-115527698.63099.010.8499.70100.070.83
21153268-115326898.45899.51
31170115-117011599.897100.96
41162046-116204699.208100.29
51146753-114675397.90298.97
61170866-117086699.961101.01
二甲双胍恩格列净片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号DC033-12306002对照品来源中检院对照品使用方法直接使用
对照品含量(%)98.99对照品水分(%)0对照品稀释倍数2000
标示量(mg)5供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.26 2391802386962389322388492395812390480.15
210.312381542378072379800.11
单位质量响应值RSD%判断
23299.0323082.440.67数据可信
供试品溶液-24052803批-恩格列净-pH6.8
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1110745-11074542.54547.759.5942.5547.759.58
2114862-11486244.12744.13
3136627-13662752.48952.49
4137203-13720352.71052.71
5115548-11554844.39144.39
6130704-13070450.21350.21
10min1187212-18721271.92277.966.1971.9978.046.20
2190648-19064873.24273.32
3215187-21518782.66982.76
4215262-21526282.69882.79
5198199-19819976.14376.22
6211066-21106681.08681.17
15min1227332-22733287.33589.603.0687.5389.813.07
2222105-22210585.32785.52
3238876-23887691.77092.00
4240487-24048792.38992.61
5236459-23645990.84291.04
6234150-23415089.95590.17
20min1238248-23824891.52991.961.1091.8792.321.11
2235825-23582590.59890.94
3241219-24121992.67093.05
4242802-24280293.27893.66
5240728-24072892.48292.83
6237466-23746691.22891.60
30min1240181-24018192.27192.191.1492.7692.701.14
2238003-23800391.43591.92
3241684-24168492.84993.38
4243723-24372393.63294.17
5240288-24028892.31392.82
6235979-23597990.65791.18
45min1241316-24131692.70892.751.6493.3593.421.64
2239138-23913891.87192.51
3247812-24781295.20395.89
4242858-24285893.30093.99
5241568-24156892.80493.46
6235943-23594390.64391.32
60min1240884-24088492.54292.190.8493.3493.010.84
2239256-23925691.91692.71
3240811-24081192.51493.36
4242272-24227293.07593.92
5240132-24013292.25393.07
6236429-23642990.83091.65
极限1245137-24513794.17593.370.7695.1394.340.75
2243395-24339593.50694.45
3243564-24356493.57194.57
4244323-24432393.86394.86
5241707-24170792.85893.83
6240135-24013592.25493.23
二甲双胍恩格列净片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号DA-11412209074对照品来源工作对照品对照品使用方法直接使用
对照品含量(%)99.9对照品水分(%)0对照品稀释倍数20
标示量(mg)500供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
19.981060782106068510649661061033106040810615750.18
210.081057537105795110577440.03
单位质量响应值RSD%判断
106370.24104934.920.97数据可信
供试品溶液-24052803批-二甲双胍-pH6.8
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1649147-64914755.24560.607.9855.2460.607.98
2667025-66702556.76656.77
3768944-76894465.44065.44
4772162-77216265.71465.71
5667092-66709256.77256.77
6747925-74792563.65163.65
10min1977892-97789283.22288.234.7583.3188.344.76
2986491-98649183.95484.05
31081057-108105792.00292.11
41085713-108571392.39892.51
51016124-101612486.47686.57
61073466-107346691.35691.46
15min11125608-112560895.79397.342.0596.0297.592.06
21107703-110770394.27094.50
31161702-116170298.86599.13
41170793-117079399.63999.90
51147758-114775897.67897.92
61149390-114939097.81798.08
20min11161268-116126898.82898.740.7999.2299.160.79
21154572-115457298.25898.65
31165292-116529299.17199.60
41175517-1175517100.041100.47
51152643-115264398.09498.50
61152424-115242498.07598.50
30min11164808-116480899.12998.720.7799.6899.300.76
21161271-116127198.82899.38
31164653-116465399.11699.71
41170757-117075799.636100.23
51149479-114947997.82598.39
61149226-114922697.80398.39
45min11168213-116821399.41998.830.71100.1499.570.71
21162556-116255698.93899.66
31162762-116276298.95599.71
41171076-117107699.663100.43
51153115-115311598.13498.86
61150225-115022597.88898.64
60min11164647-116464799.11698.550.73100.0099.450.73
21159059-115905998.64099.53
31161447-116144798.84399.77
41167020-116702099.318100.25
51146361-114636197.55998.45
61149319-114931997.81198.72
极限11168702-116870299.46198.470.79100.5199.540.79
21158441-115844198.58799.64
31159706-115970698.69599.78
41162894-116289498.966100.06
51145242-114524297.46498.52
61147175-114717597.62998.70
二甲双胍恩格列净片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号DC033-12306002对照品来源中检院对照品使用方法直接使用
对照品含量(%)98.99对照品水分(%)0对照品稀释倍数2000
标示量(mg)5供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.26 2378702378552380872379152378312379120.05
210.312395612393142394380.08
单位质量响应值RSD%判断
23188.3023223.860.11数据可信
供试品溶液-24052804批-恩格列净-pH6.8
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1103586-10358639.76835.768.7839.7735.768.78
288790-8879034.08834.09
399212-9921238.08938.09
487102-8710233.44033.44
582559-8255931.69531.70
697688-9768837.50437.50
10min1192350-19235073.84670.434.3773.9170.494.37
2177343-17734368.08468.14
3189376-18937672.70472.77
4184286-18428670.75070.81
5170858-17085865.59565.65
6186503-18650371.60171.66
15min1231792-23179288.98887.791.4089.1887.971.41
2225770-22577086.67686.85
3231923-23192389.03889.22
4230721-23072188.57788.75
5224661-22466186.25086.41
6227210-22721087.22987.41
20min1240355-24035592.27592.100.2692.6192.420.25
2239389-23938991.90492.22
3240134-24013492.19092.52
4239397-23939791.90892.23
5240753-24075392.42892.73
6239322-23932291.87992.21
30min1241705-24170592.79492.920.3093.2993.400.29
2242269-24226993.01093.48
3241400-24140092.67693.16
4241306-24130692.64093.11
5243177-24317793.35993.82
6242363-24236393.04693.53
45min1242650-24265093.15693.600.9393.8094.240.92
2243942-24394293.65294.28
3242423-24242393.06993.71
4248204-24820495.28995.92
5243501-24350193.48394.10
6242170-24217092.97293.61
60min1242036-24203692.92193.320.3693.7294.110.36
2243775-24377593.58894.37
3243012-24301293.29594.09
4242663-24266393.16193.95
5242597-24259793.13693.91
6244403-24440393.82994.62
极限1247279-24727994.93495.560.5195.8996.500.49
2249912-24991295.94496.88
3249872-24987295.92996.88
4248702-24870295.48096.42
5250088-25008896.01296.94
6247587-24758795.05296.00
二甲双胍恩格列净片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号DA-11412209074对照品来源工作对照品对照品使用方法直接使用
对照品含量(%)99.9对照品水分(%)0对照品稀释倍数20
标示量(mg)500供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
19.981055336105605110555521054959105567510555150.04
210.081054340105514310547420.06
单位质量响应值RSD%判断
105763.03104637.100.76数据可信
供试品溶液-24052804批-二甲双胍-pH6.8
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1602612-60261251.50447.456.8851.5047.446.88
2536459-53645945.85045.85
3582967-58296749.82549.83
4525491-52549144.91344.91
5505126-50512643.17243.17
6578088-57808849.40849.41
10min1978496-97849683.63080.703.4183.7280.783.42
2921468-92146878.75678.83
3969982-96998282.90382.99
4945124-94512480.77880.85
5892804-89280476.30676.38
6957466-95746681.83381.92
15min11115516-111551695.34194.581.0895.5794.791.09
21095460-109546093.62793.83
31121913-112191395.88896.11
41111683-111168395.01495.22
51091292-109129293.27193.47
61103557-110355794.31994.54
20min11141251-114125197.54197.410.3097.9297.780.31
21137473-113747397.21897.58
31143619-114361997.74398.12
41134648-113464896.97697.34
51138679-113867997.32197.68
61142641-114264197.65998.04
30min11136431-113643197.12997.420.3997.6897.960.38
21140492-114049297.47698.00
31146653-114665398.00298.55
41135141-113514197.01897.55
51142884-114288497.68098.20
61137651-113765197.23397.77
45min11136307-113630797.11897.370.3397.8398.070.33
21140628-114062897.48798.18
31144161-114416197.78998.50
41133944-113394496.91697.61
51141547-114154797.56698.25
61138957-113895797.34598.05
60min11132031-113203196.75397.130.3897.6297.990.38
21138777-113877797.32998.18
31142227-114222797.62498.49
41131191-113119196.68197.53
51138484-113848497.30498.15
61135926-113592697.08697.95
极限11131208-113120896.68296.870.3597.7197.890.34
21135491-113549197.04898.06
31136977-113697797.17598.21
41128736-112873696.47197.48
51137987-113798797.26298.27
61130149-113014996.59297.62
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